Comparative Study Between Operative and Non-Operative Management of Femoral Shaft Fractures in Ch… (NCT07483944) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study Between Operative and Non-Operative Management of Femoral Shaft Fractures in Children
Egypt46 participantsStarted 2021-01-03
Plain-language summary
The goal of this clinical trial was to compare the management of pediatric femoral shaft fractures using either Thomas splint traction or Elastic Stable Intramedullary Nailing (ESIN).
The main questions it aimed to answer were:
Did ESIN provide faster fracture healing and earlier mobilization compared with Thomas splint traction?
Were there differences in complications and functional outcomes between the two treatment methods?
Researchers compared ESIN surgical fixation with Thomas splint traction to determine which treatment provided better clinical and functional outcomes in children with femoral shaft fractures.
Participants:
Were randomly assigned to receive either ESIN surgical fixation or Thomas splint traction.
Underwent regular clinical and radiographic follow-up to assess fracture healing, alignment, and recovery.
Were evaluated for complications, time to mobilization, functional outcomes, and treatment cost during the follow-up period.
Who can participate
Age range
5 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* children aged 5 to 11 years
* patients diagnosed with acute, closed and stable femoral shaft fractures (transverse, oblique or spiral patterns)
* patients less than 45 kg in body weight.
* Written informed consent obtained from parents or legal guardians.
Exclusion Criteria:
* patients with open or pathological fractures.
* patients with unstable (segmental or comminuted) fractures.
* patient with proximal or distal physeal involvement.
* patients with associated polytrauma, multiple fractures or neurovascular injury requiring urgent surgical intervention.
* patients with neuromuscular or cognitive disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to achieve fracture bone union radiologically
Timeframe: From treatment initiation to radiographic union, up to 12 weeks.